Women around the U.S. have come forward with stories regarding painful and life-altering side effects from the permanent birth control method Essure. These women claim they were not warned about the side effects they experienced and that method is not safe. Due to the number of women with evidence of significant side effects, the U.S. Food and Drug Administration, which originally approved the birth control method, is taking a second look and altering the product’s label.
What is Essure?
Essure is a permanent birth control method for women, which is also known as sterilization. Unlike other sterilization methods, such as tubal ligation, Essure does not require surgery and can be done in about 10 minutes. Instead of surgery, flexible metal coils are inserted into the fallopian tubes through the cervix. Within approximately 3 months, tissue forms around these coils preventing eggs from being able to reach the uterus or from sperm being able to reach the eggs.
Risks Regarding Essure
Like any sterilization method, Essure comes with known side effects. However, many women are coming forward saying certain side effects were not fully explained to them or told to them at all. These side effects include:
- Chronic pain,
- Irregular bleeding,
- A rupture or tear in the fallopian tubes or uterus,
- Migration of the coils into other parts of the abdomen, and
- Allergic reactions.
There were also issues with patients having a 3-month checkup to ensure the coils were properly in place and effectively preventing pregnancy.
Many women who experience side effects must have the device taken out through a surgical procedure and need to have other reproductive organs removed as well.
New Boxed Warning
The FDA announced in February that it was taking additional steps to better inform doctors and women about potential complications with Essure. The administration is requiring Bayer, the manufacturer of Essure, to conduct a new clinical study and to include a box warning and patient decision checklist on the device. A boxed warning is the strongest warning the FDA has for patient risks regarding a drug or device.
Contact a Legal Representative
If you suffered complications due to the Essure permanent birth control method, contact Oldham & Smith to learn your legal options. You may have a claim against Bayer for a failure to warn women about the true potential risks of the implant.
Call Oldham & Smith at (352) 292-1620 or contact us online to learn more.